The recent revelation that the Changsheng Bio-Tech Co. fabricated the production records of freeze-dried rabies vaccines for human use and was linked to a substandard diphtheria-pertussis-tetanus (ADPT) vaccine for infants has aroused much attention from the public.
The direct relationship between vaccines and public health means that the production, transport, sale, management and use of such medicines are of major concern to the public. President Xi Jinping demanded that the case be carefully investigated and any wrongdoing be severely punished. Premier Li Keqiang also called for a thorough investigation into the entire process of vaccine production and sales.
Despite the recent incident, China undertakes strict management of vaccines and has a well-developed system for their production and sale. Vaccine producers are required to adhere to the rules and regulations set out in the Drug Administration Law of the People's Republic of China (DALPRC) and the Good Manufacture Practice of Medical Products (GMPMP), as well as subject to inspection by relevant watchdogs at any time.
The problematic vaccines were revealed by the China Food and Drug Administration (CFDA) during a spot check on July 5. Spot checks take the form of an on-site inspection without prior notification. According to a CFDA report issued on July 15 regarding their inspection 10 days earlier, Changsheng forged the production records and product testing records of freeze-dried rabies vaccines for human use and haphazardly altered technological parameters and equipment. The company has severely violated the DALPRC and GMPMP, and production has been halted, its Good Manufacturing Practices (GMP) Certificate revoked and all unused rabies vaccines recalled.
The Changsheng incident is not the only case of its kind in recent years. In a previous case, flaws in the transport and management of vaccines led to a large number of expired medicines in north China's Shanxi Province being administered to children.
Why do problems with vaccines in China persist despite their being a strict management system in place? The answer lies primarily with the huge profits available and the comparatively light punishment for violations of the law.
Changsheng is mainly engaged in the research, development, production and sale of vaccines for human use, with the company's annual report showing profit margins of 86.55 percent in 2017. Sharp profits are accompanied by minor legal consequences. In China, drug companies, including vaccine producers, need to abide by DALPRC, GMPMP and Criminal Law. Only when an entity is defined as having committed a crime is the Criminal Law invoked.
According to Article 141 and Article 142 of China's Criminal Law, whoever produces or sells medicine of inferior quality that causes serious harm to human health will be sentenced to prison for three to 10 years and given a fine. If the consequences are especially serious, then imprisonment is for 10 years to life, along with a corresponding fine.
If products are treated as drugs of inferior quality, the highest fines are no more than three times the sum obtained through their sale.
The vaccines produced by Changsheng are not able to be defined as fake according to current regulations. Official reports show that the rabies vaccines themselves were not problematic, but should be considered medicine of inferior quality instead. It is thus so far unclear what kind of punishment will befall the company.
As Chinese society becomes increasingly sensitive to issues concerning public health, the immoral and reckless behavior of Changsheng has caused public uproar. The Chinese Government is in the process of updating its response to such incidents, breaking away from the old practice centered on fines, while the police have already filed a case against the company bosses.
When it comes to matters related to health, regulators and law enforcers must be firm in their response by imposing strict punishments. Only in this way can China effectively stamp out such incidents and properly fulfill its responsibility to the people.
Copyedited by Laurence Coulton
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